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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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EASE TRIAL


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General
Application Number P070022 / PAS001
Current Plan Approved 07/06/2009
Study Name EASE TRIAL
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This study is a continued follow-up of subjects in the premarket EASE trial, a prospective, single-armed, multicenter study. The primary objective of the post-approval study is to determine the 3-year through 10-year, yearly period efficacy rates for subjects enrolled in the premarket EASE study.
Study Population Description The device is indicated for women who desire permanent birth control (female sterilization) by occlusion of the fallopian tubes. The study population includes women who are currently relying on the Adiana system for permanent contraception and those who are being followed for safety purposes, all from the premarket cohort.
Sample Size 770 patients, 16 sites
Data Collection Effectiveness endpoint is the pregnancy rate during the three through ten year reliance follow-up period for subjects in the EASE study who rely on the device for contraception.Safety endpoints include: (1) Subject satisfaction and comfort with device wearing; (2) Safety of device wearing; and (3) Relevant adverse events: All reproductive adverse events, and all abdominal adverse events reported during the study.
Follow-up Visits and Length of Follow-up All subjects will be assessed annually in years 3, 4, 5, 6, 7, 8, 9 and 10 post reliance or follow up date (±30 days). All visits will occur via telephone. If there is any indication that the subject may be pregnant, by either verbal admission or unusual menstrual events, an office visit will be scheduled and a pregnancy test administered within one month. The duration of follow-up is ten years.
Final Study Results
Interim Safety Information N/A The 6 month report response to deficiencies are currently under review.


EASE TRIAL Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/15/2010 01/19/2010 Overdue/Received
12 month report 07/06/2010 07/08/2010 Overdue
18 month report 01/04/2011 01/11/2011 Overdue/Received
2 year report 07/06/2011 07/14/2011 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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